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Eli Lilly’s Alzheimer’s drug Kisunla (donanemab) has been approved in Australia for treating early-stage Alzheimer’s disease in patients with confirmed amyloid pathology. < Back Eli Lilly’s Alzheimer’s Drug Kisunla (Donanemab) Receives Marketing Authorization in Australia Eli Lilly’s Alzheimer’s drug Kisunla (donanemab) has been approved in Australia for treating early-stage Alzheimer’s disease in patients with confirmed amyloid pathology. Australia’s Therapeutic Goods Administration (TGA) has approved Kisunla™ (donanemab-azbt), a monoclonal antibody developed by Eli Lilly, for the treatment of early symptomatic Alzheimer’s disease in adults with confirmed amyloid pathology. This marks the first new Alzheimer’s treatment in 25 years that targets the underlying cause of the disease by removing amyloid plaques in the brain. Kisunla is administered intravenously once a month for up to 18 months. Clinical trials have shown that it can slow cognitive and functional decline by approximately one-third compared to placebo in patients with mild cognitive impairment or mild dementia due to Alzheimer's disease. However, the treatment is not suitable for all Alzheimer's patients. Only 10–20% of Australia's estimated 400,000 dementia patients are likely to be eligible, due to strict criteria including early-stage diagnosis, specific genetic markers, and risk assessments for side effects like brain swelling and bleeding. The cost of Kisunla treatment, which includes drug and diagnostic expenses such as MRI scans and PET imaging, may exceed $80,000. Currently, it is not covered by Medicare or the Pharmaceutical Benefits Scheme (PBS). Eli Lilly has applied for PBS listing, with a review by the Pharmaceutical Benefits Advisory Committee scheduled for July. Alzheimer's disease affects around 600,000 Australians, with approximately 75% in the early stages. The disease's economic impact is projected to more than double by 2050, reaching $17 billion . Experts and advocates consider Kisunla's approval an important advance in dementia care, while emphasizing the need for improved diagnostic pathways and government support to ensure affordability and accessibility. Eli Lilly remains committed to advancing treatments for Alzheimer's disease and continues to work with regulatory authorities to expand access to Kisunla in other regions. However, currently, the National Institute for Health and Care Excellence (NICE) has not recommended Kisunla for use on the National Health Service (NHS) due to concerns about its cost-effectiveness. NICE's independent committee concluded that while Kisunla can slow cognitive decline by four to seven months, the benefit does not justify the high cost to the NHS. Author BioFocus Newsroom Previous Next

New Merck bioprocessing centre expected to open late 2026. < Back Merck's Bioprocessing Production Centre in Daejeon, South Korea New Merck bioprocessing centre expected to open late 2026. Overview Merck is set to establish a new Bioprocessing Production Centre in Daejeon, South Korea, with an investment of over €300 million. Announced in March 2024, the facility is expected to be operational by late 2026 and aims to bolster Merck’s presence in the Asia-Pacific region. Key Features: Facility Size: The centre will span 43,000m². Products: It will supply dry powder cell culture media, process liquids, and sterile sampling systems. Employment: Expected to create 300 jobs by 2028. Development: Partnering with Kolon Global for construction. Strategic importance This investment aligns with Merck’s strategy to expand its Life Science business and meet the growing demand for biologics in the Asia-Pacific market. The facility will support biotech firms and enhance collaborations with local research institutions and universities. Author BioFocus Newsroom Previous Next

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Merck has entered into an exclusive global license agreement with Hansoh Pharma to develop and commercialize HS-10270, an investigational oral GLP-1 receptor agonist for the treatment of type 2 diabetes and obesity. < Back Merck Partners with Hansoh Pharma on Oral GLP-1 Receptor Agonist for Type 2 Diabetes Merck has entered into an exclusive global license agreement with Hansoh Pharma to develop and commercialize HS-10270, an investigational oral GLP-1 receptor agonist for the treatment of type 2 diabetes and obesity. Merck & Co., Inc. (NYSE: MRK) has entered into an exclusive global license agreement with Hansoh Pharmaceutical Group Company Limited (HKEX: 3692) for the development and commercialization of HS-10270 , an investigational oral GLP-1 receptor agonist aimed at treating type 2 diabetes and obesity. This strategic partnership marks a significant milestone in both companies' efforts to expand access to effective and convenient treatments for metabolic diseases. Under the terms of the agreement, Merck will gain exclusive rights to develop and market HS-10270 outside of China, while Hansoh Pharma will retain exclusive rights for its development and commercialization within China. The collaboration aims to advance the clinical development of this oral therapy, with the goal of offering a more accessible and patient-friendly alternative to the currently available injectable GLP-1 receptor agonists. A New Oral Option for Diabetes and Obesity HS-10270 is a novel oral formulation of a GLP-1 receptor agonist designed to help manage blood sugar levels and promote weight loss—two key therapeutic goals for patients with type 2 diabetes and obesity. This class of medications works by mimicking the natural GLP-1 hormone to regulate insulin secretion, reduce glucagon production, and suppress appetite. GLP-1 receptor agonists, such as semaglutide, have already proven highly effective in controlling blood glucose levels and aiding weight loss. However, the availability of these drugs in an oral form could expand patient access, as oral medications are generally preferred over injectable therapies for their ease of use and convenience. Early clinical trials of HS-10270 have shown positive results, including improvements in both glycemic control and body weight management. The oral formulation could provide a significant advantage over injectable alternatives, especially for patients who may have difficulty with injections or prefer non-injection-based treatments. Merck's Metabolic Disease Portfolio Merck’s collaboration with Hansoh Pharma will enhance its portfolio in the growing areas of diabetes and obesity management. "We are excited to collaborate with Hansoh Pharma on HS-10270 , an investigational oral GLP-1 receptor agonist that has the potential to offer patients a convenient and effective treatment option for managing type 2 diabetes and obesity," said Dr. Roger M. Perlmutter, President of Merck Research Laboratories. "This agreement further underscores our commitment to advancing breakthrough therapies for patients suffering from chronic conditions with significant unmet medical needs." In addition to its strong presence in oncology and vaccines, Merck has been expanding its diabetes and obesity pipeline, recognizing the increasing global burden of these diseases. The partnership with Hansoh Pharma represents a significant step toward providing more comprehensive solutions for metabolic disorders, which affect millions of people worldwide. Terms of the Agreement The agreement includes an upfront payment to Hansoh Pharma, as well as potential milestone payments tied to the successful development, regulatory approvals, and commercialization of HS-10270 . Hansoh Pharma will also receive royalties on the product's sales outside China. As part of the deal, Hansoh will continue to manage ongoing clinical trials in China and lead efforts toward regulatory approvals in that region. Merck’s global rights to HS-10270 outside of China reflect the company’s strategy to expand its leadership in metabolic disease treatments, with an emphasis on oral therapies, which are becoming increasingly preferred by patients. About Merck Merck is a global healthcare leader focused on creating innovative medicines, vaccines, biologic therapies, and animal health products. With a robust pipeline targeting critical areas such as oncology, cardiovascular diseases, and metabolic disorders, Merck is dedicated to improving patient outcomes and advancing healthcare worldwide. The company is committed to addressing unmet medical needs through science and innovation. About Hansoh Pharmaceutical Hansoh Pharmaceutical Group is one of China’s leading biopharmaceutical companies, focused on the discovery, development, and commercialization of novel therapies in oncology, central nervous system diseases, and metabolic diseases. The company has built a broad and diverse portfolio of innovative medicines and is expanding its presence in both domestic and international markets. Hansoh is particularly active in the development of treatments for type 2 diabetes and obesity, with a growing pipeline in these areas. Author BioFocus Newsroom Previous Next

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First commercial cell culture solution tailored for HEK293 cells in perfusion, enabling high-density growth, scalable viral vector production, and consistent quality for advanced therapies. < Back FUJIFILM Biosciences Unveils HEK293 Perfusion Medium for Gene Therapy First commercial cell culture solution tailored for HEK293 cells in perfusion, enabling high-density growth, scalable viral vector production, and consistent quality for advanced therapies. FUJIFILM Biosciences has unveiled BalanCD HEK293 Perfusion A, the first commercially available cell culture medium tailored specifically for HEK293 cells in perfusion processes. The launch marks a significant step forward in enabling scalable, high-quality viral vector production for gene therapies. HEK293 cells are widely used in upstream bioprocessing for gene therapy, offering strong growth rates and high transfection efficiency. BalanCD HEK293 Perfusion A builds on these advantages, supporting high-density (HCD) and intensified cultures while maximizing cell growth, viability, and productivity. The medium is designed for a broad range of applications, from Adeno-Associated Virus (AAV) and Lentivirus (LV) production to transient protein and recombinant protein expression. Optimized for steady-state and intensified perfusion, the medium is compatible with multiple transfection methods and cell retention devices, making it versatile across workflows. Its continuous processing capabilities support both laboratory-scale research and large-scale commercial manufacturing. By improving process consistency and scalability, FUJIFILM’s new solution addresses key bottlenecks in gene therapy development. “With BalanCD HEK293 Perfusion A medium, we have introduced a new way to advance gene therapies, building on a family of high-performing HEK293 products to provide more consistent, high-quality resources across the treatment spectrum,” said Erik Vaessen, Chief Business Officer at FUJIFILM Biosciences. “This innovative approach is another example of how we are working with our partners to bring breakthrough therapies to more patients worldwide.” The introduction of BalanCD HEK293 Perfusion A reflects FUJIFILM Biosciences’ commitment to supporting the next generation of advanced therapies, providing reliable solutions that help reduce costs, maximize efficiency, and accelerate the path from research to clinical and commercial production. Author BioFocus Newsroom Previous Next

The collaboration highlights growing efforts to overcome manufacturing hurdles in gene therapy and bring treatments for debilitating neuromuscular junction diseases closer to patients. < Back Andelyn and Amplo Partner to Scale AAV Manufacturing for NMJ Disorders The collaboration highlights growing efforts to overcome manufacturing hurdles in gene therapy and bring treatments for debilitating neuromuscular junction diseases closer to patients. Andelyn Biosciences, Inc., a leading cell and gene therapy contract development and manufacturing organisation (CDMO), has entered into a partnership with Amplo Biotechnology to accelerate the production of clinical-grade adeno-associated virus (AAV) material for therapies targeting neuromuscular junction (NMJ) disorders. The collaboration will leverage Andelyn’s proprietary suspension AAV Curator® platform, a scalable system designed to optimise AAV vector production and streamline the path to cGMP and commercial manufacturing. NMJ disorders are a group of rare but serious conditions caused by genetic mutations affecting the junctions between nerves and muscles. These disruptions impair signal transmission, leading to progressive muscle weakness that, in severe cases, can necessitate respiratory support, tube feeding, or the use of wheelchairs. While these diseases are often diagnosed in childhood, symptoms can also present later in life, creating challenges for timely diagnosis and treatment. Gene therapy has emerged as a promising approach to NMJ conditions because AAV vectors can deliver functional copies of faulty genes directly to affected tissues, potentially addressing the root cause of the disease rather than just managing symptoms. However, the complexity and cost of manufacturing high-quality viral vectors at a clinical scale have historically slowed the translation of these therapies into trials. Andelyn’s Curator® platform aims to address that bottleneck. According to Matt Niloff, Chief Commercial Officer at Andelyn Biosciences, “Andelyn Biosciences suspension AAV Curator platform is a highly characterised, scalable suspension AAV platform that leverages a data-driven approach to adapt and optimise customer processes while providing a pathway to cGMP and commercial manufacturing. As a leading clinical and commercial CDMO, we are honoured to support Amplo Biotechnology’s efforts to bring hope to patients affected by debilitating NMJ diseases. Our Curator® platform and end-to-end capabilities are designed to help partners achieve key development and clinical milestones.” For Amplo Biotechnology, the partnership represents an opportunity to move its preclinical pipeline closer to clinical evaluation. The company focuses on regenerative AAV medicines for NMJ-affecting conditions, a category that includes diseases such as congenital myasthenic syndromes and Lambert-Eaton myasthenic syndrome. In a statement, the company said the collaboration “strengthens its ability to deliver high-quality AAV material and supports its mission to develop transformative therapies for families impacted by genetic NMJ disorders worldwide.” Based in Columbus, Ohio, Andelyn Biosciences has become a prominent player in the gene therapy manufacturing ecosystem, known for its expertise in viral vector development and large-scale production. The company emphasises that partnerships like this are critical to advancing gene therapy from discovery into the clinic, noting that “by collaborating with leading organisations such as Amplo Biotechnology, Andelyn is at the forefront of advancing life-changing gene therapies… and transforming the landscape of healthcare through the development of groundbreaking treatments.” The partnership underscores a growing trend in the biotechnology sector: specialised CDMOs and small, innovative biotech companies joining forces to overcome the manufacturing and regulatory hurdles of gene therapy. For NMJ disorders, where effective treatments are scarce, this collaboration could accelerate the path toward much-needed clinical trials and, ultimately, patient access. Author BioFocus Newsroom Previous Next

< Back Unlocking the Mystery of Long COVID: A Serotonin Connection Recent research has unveiled a promising new insight that may help unravel the mysteries surrounding Long COVID. Introduction Following the COVID-19 pandemic, society is grappling with an unprecedented health challenge: post-acute sequelae of viral infection (PASC), more colloquially known as "Long COVID." This condition has perplexed researchers and clinicians, with no definitive understanding of its root cause and no effective treatments discovered to date. PASC presents a spectrum of persistent symptoms, including fatigue, shortness of breath, cognitive impairment, and more, which can linger for months after the initial infection has resolved. However, a recent research paper has unveiled a promising new insight that may help unravel the mysteries surrounding Long COVID. The Pathophysiology of Long COVID The pathophysiology of Long COVID remains undetermined. Researchers have put forth several hypotheses. These include viral persistence, chronic inflammation, hypercoagulability, and autonomic dysfunction, all of which have been proposed as contributors to Long COVID. However, a recent study suggests that there may be a single thread that connects these hypotheses: serotonin, a neurotransmitter crucial for numerous physiological and psychological functions in the human body. The study involved evaluating a wide range of biochemical parameters in Long COVID patients, including serotonin levels, tryptophan absorption rates, platelet function, and MAO activity, as well as assessing the cognitive and memory function of these patients via neuropsychological tests. The research posits that the common denominator in Long COVID may be a reduction in serotonin. The Serotonin-SARS-CoV-2 Connection The link between SARS-CoV-2 infection and serotonin reduction is complex, however, the research team have proposed three key mechanisms through which this reduction occurs: Diminished Tryptophan Absorption: Tryptophan is a precursor for serotonin production, and its absorption in the intestine is critical for maintaining serotonin levels. Viral infection, particularly with SARS-CoV-2, appears to hinder the body's ability to absorb tryptophan effectively. Platelet Hyperactivation and Thrombocytopenia: Another crucial aspect is the impact of viral infection on platelets (small blood cells involved in clotting). In Long COVID patients, hyperactivation of platelets combined with thrombocytopenia (a decrease in platelet count) leads to disturbances in serotonin storage. This can result in lower serotonin levels in the bloodstream. Enhanced MAO-Mediated Turnover: Monoamine oxidase (MAO) is an enzyme that plays a key role in breaking down serotonin. In Long COVID, viral infection appears to enhance MAO activity, leading to a faster turnover of serotonin, further depleting its levels. Impaired Vagus Nerve Function and Cognitive Effects Serotonin, with its various roles in the body, has wide-reaching implications for health. One of its critical functions is its influence on the vagus nerve, a major component of the autonomic nervous system. The research paper posits that peripheral serotonin reduction affects the activity of the vagus nerve. This, in turn, has implications for the brain, specifically the hippocampus, a region associated with memory and cognitive function. When serotonin levels are diminished, the vagus nerve's function is impaired, leading to disruptions in hippocampal responses and memory. This could explain the neurocognitive symptoms observed in Long COVID patients, providing a potential link between viral persistence and cognitive impairment. Possible Therapeutic Implications The research findings open up potential new avenues for therapeutic interventions in Long COVID. If serotonin reduction indeed lies at the core of the condition, addressing this deficit could potentially alleviate symptoms and enhance recovery. Tryptophan Supplementation: Boosting tryptophan levels through dietary or supplemental means may help restore serotonin production, especially in Long COVID patients who struggle with intestinal absorption. Platelet Function Regulation: Investigating ways to mitigate platelet hyperactivation and thrombocytopenia might prevent serotonin storage disturbances, thus maintaining healthier serotonin levels. MAO Inhibitors: Medications that inhibit MAO, the enzyme responsible for serotonin breakdown, could be explored as a strategy to slow down serotonin turnover. Vagus Nerve Stimulation: Targeting the vagus nerve through neuromodulation techniques may help restore its function and improve cognitive symptoms. The Promise of Further Research The revelation of the serotonin connection in Long COVID represents a signific ant milestone in our understanding of this perplexing condition. However, more research is required to validate these findings and determine their clinical relevance fully. Long COVID is clearly a complex condition, and serotonin is likely to be just one piece of the overall puzzle. Nevertheless, this discovery provides hope for patients and medical professionals hoping to piece together enough of the jig-saw to develop effective therapies for the condition. Author BioFocus Newsroom Previous Next

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